Status unknownNCT06394154Updated May 2, 2024

Validation of a Mental Health Scale for Young People With Chronic Stomach Symptoms

An observational study in Functional Gastrointestinal Disorders, Gastroparesis and Vomiting; Cyclical, sponsored by Greg O'Grady. Status unknown. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Greg O'Grady · Observational

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Not yet recruiting — may be out of date.

Study type: Observational
Model: Case-only
Time perspective: Cross-sectional
Enrollment: 100
Ages: 12 Years to 17 Years
Sex: All

Study summary

This study aims to validate the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW-Y), a mental health scale developed for patients aged 12-17 years with chronic stomach symptoms.

Read the detailed description

There is currently a lack of validated questionnaires developed to assess mental health within patients with chronic stomach symptoms. Our team has therefore developed and validated a new mental health scale for patients with gastroduodenal symptoms, the Alimetry® Gut-Brain Wellbeing (AGBW) Survey.

However, the AGBW Survey was developed and validated for patients aged 18 years and over. Therefore, the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW- Y) was developed for use in patients with chronic gastroduodenal symptoms aged 12-17 years. This scale is adapted from the adult AGBW Survey, with more appropriate wording for this age group.

This study will distribute an anonymous, online survey to adolescent patients with chronic gastroduodenal symptoms aged 12-17 years. This survey will ask questions about a patient's general demographics, gastrointestinal symptoms, and mental health in order to assess the validity and reliability of the AGBW-Y.

Conditions studied

Functional Gastrointestinal Disorders
Gastroparesis
Vomiting; Cyclical
Nausea
Vomiting
Rumination Syndrome
Aerophagy
Dyspepsia

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In context

Gastrointestinal Diseases

639 studies on the registry are indexed under Gastrointestinal Diseases; 126 are open to participants now.

This study's planned enrollment of 100 is below the median of 350 across 195 observational studies indexed under Gastrointestinal Diseases.

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Lead sponsor

Greg O'Grady is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients with chronic gastroduodenal symptoms aged 12-17 years

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Aged 12-17 years
Able to read and write fluently in English
Meet the Rome IV criteria and/or have a self-reported previous clinical diagnosis for at least one of the following childhood gastroduodenal DGBIs: gastroparesis, cyclic vomiting syndrome, functional nausea, functional vomiting, rumination syndrome, aerophagia, or functional dyspepsia

Exclusion criteria

Exclusion Criteria:

Patients with self-induced vomiting
Patients with an eating disorder

Study design

Observational model: Case-only
Time perspective: Cross-sectional
Enrollment: 100 participants (estimated)
Patient registry: No

What researchers measure

Primary outcomes

Internal Consistency Reliability of the AGBW-Y total score and subscales
Measured via Cronbach's alpha and item-total correlations
Time frame: Baseline
Convergent Validity of the AGBW-Y total score and subscales
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Patient Health Questionnaire for Adolescents (PHQ-A), the Generalized Anxiety Disorder- 7 (GAD-7), the PROMIS Pediatric Psychological Stress Experiences Short Form 8a (PPSE), the Depression Anxiety and Stress Scale Youth Version (DASS-Y), and the Kessler Psychological Distress Scale (K10)
Time frame: Baseline
Divergent Validity of the AGBW-Y total score and subscales
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Big Five Questionnaire for Children (BFQ-C) energy/extraversion subscale and the the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Time frame: Baseline
Concurrent Validity of the AGBW-Y total score and subscales
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Pediatric Quality of Life Inventory 4.0 (PedsQL)
Time frame: Baseline

Study locations

No study locations are listed for this record.

References and documents

Publications

Law M, Humphrey G, Pickering I, Schamberg G, Varghese C, Du P, Daker C, Mousa H, Gharibans A, O'Grady G, Andrews CN, Calder S. Validation of the youth version of the Alimetry(R) Gut-Brain Wellbeing Survey: a mental health scale for young people with chronic gastroduodenal symptoms. World J Pediatr. 2026 Apr;22(4):465-476. doi: 10.1007/s12519-026-01027-4. Epub 2026 Apr 29. PubMed 42056628 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2024; primary completion for Sep 2024, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 28, 2024
First posted: May 1, 2024
StartEst.: May 2024
Primary completionEst.: Sep 2024
CompletionEst.: Sep 2024
Last update: May 2, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06394154
Lead sponsor: Greg O'Grady
Collaborators: University of Auckland, New Zealand
Responsible party: Greg O'Grady (Professor, University of Auckland, New Zealand) — Sponsor-investigator
First posted: May 1, 2024
Start date: May 2024 (estimated)
Primary completion: Sep 2024 (estimated)
Completion: Sep 2024 (estimated)
Last update: May 2, 2024

Study contacts

Mikaela Law, PhD

Contact

m.law@auckland.ac.nz

+64 9 923 9820

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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